Tongue Coblation via the Ventral Approach for Obstructive Sleep Apnea Hypopnea Syndrome Surgery

Transcription

1 The Laryngoscope VC 2012 The American Laryngological, Rhinological and Otological Society, Inc. Tongue Coblation via the Ventral Approach for Obstructive Sleep Apnea Hypopnea Syndrome Surgery Tiening Hou, PhD; Sunhong Hu, PhD; Xiaohua Jiang, BS Objectives/Hypothesis: To determine the safety and efficacy of tongue Coblation via the ventral approach in the treatment of hypopharyngeal obstruction for patients with obstructive sleep apnea hypopnea syndrome (OSAHS). Study Design: Prospective case control study. Methods: Tongue Coblation was performed under local anesthesia in one session in 40 inpatients diagnosed with OSAHS with predominant hypopharyngeal obstruction after failed uvulopalatopharyngoplasty. In the ventral approach (n ¼ 20), only one puncture point was applied at the center of lingual frenulum, and 12 radiofrequency volumetric tissue reduction (RFVTR) lesions were implanted in the tongue. In the dorsal approach (n ¼ 20), eight RFVTR lesions were distributed on the tongue. Using portable polysomnography (PSG) and the Epworth sleepiness questionnaire (ESQ), we followed 36 patients for 1 year after the operation. Good outcome was defined as apnea hypopnea index <20 or reduction >50%. Results: In the ventral approach, total energy was accumulated to 23,000 J in 12 lesions, with postoperative pain 2 3 by visual analog scale (VAS). There was only one case of moderate venous bleeding and hematoma. The ESQ comparison indicated subjective improvements in patients, and PSG showed a curative effect in 11 of 19 (61.11%, eight of 19 success plus three of 19 responders), with a failure rate of eight of 19. By contrast, in the dorsal approach, total energy was 16,000 J, with postoperative pain 3 4 (VAS). Complications included mild to moderate tongue venous hematoma, severe infection of tongue, and temporary mild glossal deviation. A curative effect was seen in six of 17, with a failure rate of 11 of 17. Conclusions: Tongue Coblation via the ventral approach is an effective and safe technique to treat hypopharyngeal obstruction in OSAHS surgery. Key Words: Obstructive sleep apnea syndrome, radiofrequency, ventral tongue, lingual artery, microinvasive tongue surgery, Coblation. Level of Evidence: 3b. Laryngoscope, 122: , 2012 INTRODUCTION In recent history, several surgeries have been developed with the aim of reducing the volume of the tongue base and subsequently increasing the size of the retrolingual airway for the treatment of obstructive sleep apnea hypopnea syndrome (OSAHS). These surgeries included CO 2 midline laser glossectomy, 1 maxillomandibular advancement, 2 tongue base suspension, 3 genioglossus advancement, 4 hyoid suspension, 5 and submucosal minimally invasive lingual excision. 6 These surgical techniques are effective to a certain degree. However, these procedures are sometimes associated with severe complications, such as edema, infection, bleeding, lingual paralysis, and persistent odynophagia. Powell et al. demonstrated that treatment of isolated animal tongue with From the Department of Otolaryngology Head and Neck Surgery, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China. Editor s Note: This Manuscript was accepted for publication June 11, The authors have no funding, financial relationships, or conflicts of interest to disclose. Send correspondence to Sunhong Hu, PhD., Department of Otolaryngology Head and Neck Surgery, Sir Run Run Shaw Hospital, affiliated with School of Medicine, Zhejiang University, Hangzhou , China. sunhonghu@hotmail.com DOI: /lary radiofrequency (RF) resulted in volume reduction of tongue base. 7 As a result, the technique of RF volumetric tissue reduction (RFVTR) for tongue Coblation as a microinvasive procedure was introduced into the treatment of OSAHS. It has certain clinical values, including an enlarged postoperative retrolingual cross-sectional area and great reduction in the respiratory disturbance index Currently, the most common technique of tongue Coblation is performed via the dorsal approach, which is confined to a relatively narrow area that is susceptible to greater mucus membrane destruction. Riley had described a ventral approach as an adjunctive method in which a limited amount of energy was delivered to the tongue via the ventral approach. 11 Therefore, the management of hypopharyngeal obstruction remains a challenge, and the techniques for performing tongue Coblation still need to be improved. The goal of this pilot study was to assess the technique of tongue Coblation via the ventral approach with respect to its safety and effectiveness. We hope that this novel technique will lead to improved tolerability of OSAHS treatment. MATERIALS AND METHODS Population The objective of the study was to evaluate the efficacy of tongue Coblation via the ventral approach, particularly in

2 TABLE I. Details of Patients Designated for Tongue Coblation. Subject Ventral Approach Dorsal Approach Age, yr Weight, kg Height, cm ASA grade, 1/2/3 6/13/1 7/13/0 BMI, kg/m AHI Lowest SpO 2 (%) ASA ¼ American Society of Anesthesiologists; BMI ¼ body mass index; AHI ¼ apnea hypopnea index; SpO 2 ¼ arterial oxyhemoglobin saturation. comparison to the dorsal approach. This prospective, nonrandomized case control study was approved by the Medical Ethics Committee of Zhejiang University School of Medicine. Two matched groups of 20 patients with primary complaint of snoring and polysomnographic evidence of moderate to severe OSAHS after failed uvulopalatopharyngoplasty were studied. These patients also showed continuous positive airway pressure (CPAP) refusal or intolerance. One group underwent treatment with a novel technique via the ventral approach, and the other underwent a time-tested technique via the dorsal approach. Both groups are compared in regard to differences in the complications, efficacy, pain, and treatment results. Based on the inclusion criteria, 19 males and one female in the ventral group and 18 males and two females in the dorsal group participated in the study (Table I). Exclusion criteria were as follows: severe impairment of cardiorespiratory function, psychiatric/emotional disorder, hypothyroidism, mean body mass index >32, age >70 years, and severe nasal and oropharyngeal obstruction. The clinical series routine assessments consisted of clinical history, physical examination, evaluation of daytime sleep using the Epworth sleepiness questionnaire (ESQ), electrocardiogram, x- ray of chest, and a routine laboratory test including thyroid gland function. Special tests included all-night portable polysomnogram (PSG; Xinxing, Beijing, China) and diagnosis of the obstruction level in the upper airway using a 16-slice spiral CT (Siemens, Erlangen, Germany) when the patient was in a druginduced controllable sleep condition. The obstruction level diagnosis found that the predominant obstruction was in the hypopharyngeal region, and the tongue Coblation via the ventral or the dorsal approach as a sole procedure was designed on schedule. The diagnosis of all 40 cases of OSAHS used the diagnostic criteria of the American Academy of Sleep Medicine. 12 Written informed consent was obtained from each patient. after taking the needle electrode out of the tongue and slightly reducing the angle of the Coblator needle electrode of reflex 55 to 30, another six RFVTR lesions in the region 10 mm along the tongue midline in the sagittal direction from the circumvallate papilla toward the bottom of the epiglottic vallecula were implanted bilaterally in the tongue base, as shown in Fig. 1. In the dorsal approach, six RFVTR sites were implanted bilaterally about 5 mm along the tongue midline from posterior tongue base to anterior tongue body, and two RFVTR sites were implanted on each inner side <1.0 cm lateral to the periphery of the tongue body. The minimum interval between RFVTR lesions should be >10 mm. RFVTR for about 12 seconds at about 1,920 J was delivered to each RFVTR lesion with a dynamic needling style. Electric conduction paste plus a little polyvinylpyrrolidone-iodine was used as plasma medium. All of the surgical procedures were performed by a single surgeon (T.N.H.) while monitoring anesthesia care with intravenous conscious analgesia/sedation. Postoperative Management In both groups, the patients were kept on oxygen supply if necessary. Bedside monitoring with pulse oxymetry was used for the first night. Oropharynx parichnos was prepared by the bedside. To reduce severe swelling of the tongue and sialorrhea, the patient should keep ice in his/her mouth as soon and as long as possible immediately following surgery. Patients should receive a 40-mg dose of intravenous methylprednisolone sodium succinate every 8 hours for the first 48 hours after surgery, along with intravenous omeprazole, antibiotics, and other antiswelling medications. A liquid or semiliquid diet should be imposed for at least 1 week following surgery. Patients are usually discharged 72 hours after surgery and given a 14-day Surgical Technique of Tongue Coblation Tongue Coblation was performed under local anesthesia by a Coblator needle electrode of reflex 55 with a Coblator setting of 6 (ENTec-Coblator Surgery System I; ArthroCare, Sunnyvale, CA). The puncture point in the ventral approach was designed at the lateral lingual frenulum and 5 mm above the sublingual caruncle. The Coblator needle electrode of reflex 55 was pushed directly into the inferior part of the intrinsic lingual muscles via the ventral mucous membrane. Usually, 12 RFVTR lesions were implanted in the tongue in one session. First, four RFVTR lesions were implanted in order along the anterior 2 mm of the circumvallate papilla and at both sides of the tongue body. An additional 2 RFVTR lesions were implanted in the area of the anterior 9 mm of the circumvallate papilla and about 10 mm of the tongue midline. Finally, Fig. 1. The arrangement of radiofrequency volumetric tissue reduction (RFVTR) lesions on the tongue in Coblation via the ventral approach in a level plane view of the tongue. 2583

3 TABLE II. Differents Between the Ventral and the Dorsal Approach. Subject Ventral Approach Dorsal Approach Surgical cure rate 57.8% (8/19) 41.1% (6/17) Energy dose 23,000 J 12,800 J Pain Mild Moderate Oral care Simple Intensive Complication Seldom At times Pharyngeal paresthesia Slight Obviously Fig. 2. The final effect of radiofrequency volumetric tissue reduction (RFVTR) lesions on the tongue in Coblation via the ventral approach in a lateral view of the tongue. HLNVB ¼ hypoglossal/ lingual artery neurovascular bundle. course of oral antibiotics and other medications of symptomatic treatment. Complications In the ventral approach, only one case of moderate vein bleeding from the RF fistula with formation of hematoma occurred during the procedure; this was controlled by a suture ligature around the responder site. No severe negative sequelae on the tongue occurred postoperatively. None of the patients had severe complications or needed intensive care unit observation or temporal tracheotomy. In the dorsal approach, there was one case of moderate tongue venous hematoma, one case of moderate infection of the tongue, and one case of temporary mild glossal deviation. Statistical Analysis Two-tailed unpaired Student t tests for data collected as mean 6 standard deviation (SD) were performed using Graph- Pad Prism (Spass1.3, version 3.02 for Windows Xp; GraphPad Software, La Jolla, CA). P <.05 was considered statistically significant. RESULTS In the ventral approach, all of the procedures were carried out smoothly with excellent patient tolerance. In typical cases, this procedure lasted about 10 minutes without visible bleeding, and the RFVTR time in the tongue lasts only about 3 minutes, with only one puncture of orificium fistula at the ventral tongue and sparing of the mucous membrane of the dorsal tongue. In general, the total energy was accumulated to 23,000 J in 12 lesions. Via observation after surgery, we found that tongue Coblation via the ventral approach initially causes tongue swelling and immobilization. The swelling of the tongue developed to an extreme degree at about 3 hours postoperation. Then it subsided gradually following the administration of steroids, antiswelling medications, and oral ice cubes; it subsided obviously after 24 hours and basically after 48 hours. The patients underwent a mild to moderate and temporal speaking and swallowing disorder due to the swelling of the tongue in the immediate postoperative period, which lasted about 10 hours. Therefore, each patient was advised to keep ice in the mouth until midnight. During this time, it is enough for a few patients who need an oropharynx parichnos to keep on their breath when they feel oropharyngeal obstruction. There were no clinically significant complications in the ventral group such as hemorrhage, clinically significant infections, respiratory problems, and severe swallowing difficulty postoperatively. Usually, the mean postoperative pain degree was about 2 3 on a visual analogue scale (VAS). If the patient complained of moderate odynophagia, it was necessary to give nonsteroidal analgesics, although this was not common. Generally, postoperative nursing care was very simple. The RFVTR lesions eventually cause some scar formation and tongue fibrosis, which subsequently results in a stronger tongue base support and reduced compliance of the tongue to prevent hypopharyngeal collapse. The final effect of RFVTR was shown as in Fig. 2. One patient was lost to follow-up after the surgery. Therefore, 19 patients were followed up after the tongue Coblation for a period of 1 year with physical examination, evaluation of daytime sleep using the ESQ, and full-night portable PSG test. According to the popular curative effect criterion, patients were considered to have TABLE III. Results of Follow-up (Mean 6 Standard Deviation). Subject Group, n ¼ 20 Preop (95% CI) Postop (95% CI) P AHI Ventral ( ) ( ) <.01 Dorsal ( ) ( ) <.00 ESQ Ventral ( ) ( ) <.36 Dorsal ( ) ( ) <.11 Weight, kg Ventral ( ) ( ) <.00 Dorsal ( ) ( ) <.00 Preop ¼ preoperative; CI ¼ confidence interval; Postop ¼ postoperative; AHI ¼ apnea hypopnea index; ESQ ¼ Epworth sleepiness questionnaire. 2584

4 had successful outcome if the postoperative PSG demonstrated an apnea hypopnea index (AHI) <20 and the patient reported significant clinical improvement. Eight patients met our polysomnographic and clinical criteria for surgical success. In addition, three of our patients with AHIs <20 but without complete disappearance of daytime symptoms would have been classified as responders. Thus, the curative effect was 11 of 19 (57.8%, success plus responder). However, nine cases of patients with remaining postsurgery symptoms in our study also showed AHIs >20 and hypersomnia, and consequently were classified in the failure group (nine of 11, 42.2%). In the dorsal group, there were eight puncture points on the dorsal surfaces, and the mean short-term postoperative pain degree was about 3 4 by VAS; patients experienced odynophagia at postoperative days 3 to 5, although not before or after, and a heavy greasy coating on the tongue. Therefore, these patients need a intensive oral care. Three patients were lost to followup. Thus, the curative effect rate was six of 17 (41.11%, success plus responder), and the failure rate was 11 of 17 (59%). The difference between the ventral and the dorsal approach were shown in Table II. Data were expressed as the mean 6 SD with 95% confidence intervals, as shown in Table III. There was no statistically significant difference in the weights of patients before and after surgery in both groups. Three patients showed improvement in the immediate follow-up period. Unfortunately, the patients showed recurrence of symptoms due to being overweight after the surgery. Other failures seen were due to residual narrowing and obstruction in the oropharyngeal region or nasal obstruction. Patients for whom tongue Coblation failed and who were still symptomatic had a significant number of apneas, retained multilevel obstruction, and consequently required additional treatment. Therapeutic alternatives in these patients may be bimaxillary advancement or another nasal CPAP attempt. DISCUSSION Tongue Coblation via the ventral approach was performed with the ENTec-Coblator system with the needle in the upward and forward directions, and the total energy was accumulated to 23,000 J in one session. The middle of the lingual frenulum was regarded as a safe inferior border of the tongue. This technique avoided injury to the hypoglossal/lingual artery neurovascular bundle, including the deep lingual artery and the dorsal artery. Thus, this technique improved the clinical application of tongue Coblation, reducing tissue volume and compliance of the tongue in the treatment of hypopharyngeal obstruction in patients with OSAHS. Comparison of this approach with tongue Coblation via the dorsal approach shows that tongue Coblation via the ventral approach is a safer procedure due to the needling direction being far from the main lingual artery. Once the needle electrode passes through the ventral mucous membrane and the deep lingual artery, only the dorsal arteries need to be dealt with in the tongue Coblation procedure. In this condition, the Coblator needle electrode can be moved around the greater area of the tongue, including 5 mm posterior of the deep lingual artery, 2 mm anterior of the circumvallate papilla in the tongue body, and within 10 mm of the midline in the tongue base. Therefore, the operative complications can be minimized or avoided. Because the puncture point is at the lateral lingual frenulum, it decreases the chance of tongue infection, as the wound is separated from oral germ conditions and gastroesophageal reflux. Conversely, the discharge from the wound can be easily eliminated via the RF passage with the help of gravitational force. This has the positive effect of relieving swelling of the tongue after the RFVTR. As a result, there is little postoperative danger of heavy tongue obstruction, even in the condition of tongue venous hematoma. In addition, administration of medications to relieve swelling and oral ice cubes is an important method to treat postoperative tongue swelling. The results of follow-up demonstrate that tongue Coblation via the ventral approach is an effective surgical modality. The effect of volumetric tissue reduction is obvious, especially for tongue hypertrophy. Even in cases of craniofacial abnormalities, such as micromandible, tongue Coblation via the ventral approach is a better modality to reduce tongue volume and permits a significant enlargement of the hypopharyngeal airway without injury of the lingual function in OSAHS treatment. It could produce not only efficacious volumetric tissue reduction and pillar potency, but also additional suspension effectiveness of the tongue base as the scarring is completed. 13 In our opinion, the purpose of accumulating total energy to 23,000 J at least in one session is to reduce the frequency of the session and also to cause stronger scarring, which should help to ensure its long-term efficacy. The energy settings we used here are higher than those previous reported. 14 Maintaining weight after surgery can also help in the long term. In our experience, in comparison with dorsal approach, tongue Coblation via the ventral approach is a tolerable operation for patients. Because of sparing of the membrane of the dorsal tongue, it usually results in mild postoperative pain, simplifies postoperative nursing care, and seldom requires multiple procedures. There is also a low incidence of postoperative pharyngeal paresthesia and a heavy, greasy coating on the tongue. Therefore, this surgical operation can be easily tolerated by patients with OSAHS. These favorable results have produced long-term objective (portable PSG) and subjective patient improvement. However, the failure cases indicate that the outcome of tongue Coblation can be limited by residual palatal obstruction, even after palate surgery 15 or nasal obstruction. One disadvantage is that tongue Coblation via the ventral approach is not a procedure that can be directly viewed. Therefore, it is a challenge to deal with severe arterial bleeding. In this condition, it is likely beneficial to perform a suture ligation of the bleeding site. 2585

5 CONCLUSION Tongue Coblation via the ventral approach is an effective and safe technique to treat hypopharyngeal obstruction in OSAHS surgery. The total energy can be accumulated to 23,000 J in one session. BIBLIOGRAPHY 1. Fujita S, Woodson BT, Clark JL, Wittig R. Laser midline glossectomy as a treatment for obstructive sleep apnea. Laryngoscope 1991;101: Prinsell JR. Maxillomandibular advancement surgery in a site-specific treatment approach for obstructive sleep apnea in 50 consecutive patients. Chest 1999;116: DeRowe A, Gunther E, Fibbi A, Lehtimaki K, Vahatalo K, Maurer J, Ophir D. Tongue-base suspension with a soft tissue-to-bone anchor for obstructive sleep apnea: preliminary clinical results of a new minimally invasive technique. Otolaryngol Head Neck Surg 2000;122: Neruntarat C. Genioglossus advancement and hyoid myotomy: short-term and long-term results. J Laryngol Otol 2003;117: Hormann K, Baisch A. The hyoid suspension. Laryngoscope 2004;114: Maturo SC, Mair EA. Submucosal minimally invasive lingual excision: an effective, novel surgery for pediatric tongue base reduction. Ann Otol Rhinol Laryngol 2006;115: Powell NB, Riley RW, Troell RJ, Blumen MB, Guilleminault C. Radiofrequency volumetric reduction of the tongue. A porcine pilot study for the treatment of obstructive sleep apnea syndrome. Chest 1997;111: Li KK, Powell NB, Riley RW, Guilleminault C. Temperature-controlled radiofrequency tongue base reduction for sleep-disordered breathing: longterm outcomes. Otolaryngol Head Neck Surg 2002;127: Stuck BA, Kopke J, Hormann K, Verse T, Eckert A, Bran G, Düber C, Maurer JT. Volumetric tissue reduction in radiofrequency surgery of the tongue base. Otolaryngol Head Neck Surg 2005;132: Neruntarat C, Chantapant S. Radiofrequency surgery for the treatment of obstructive sleep apnea: short-term and long-term results. Otolaryngol Head Neck Surg 2009;141: Riley RW, Powell NB, Li KK, Weaver EM, Guilleminault C. An adjunctive method of radiofrequency volumetric tissue reduction of the tongue for OSAS. Otolaryngol Head Neck Surg 2003;129: The International Classification of Sleep Disorders: Diagnostic and Coding Manual. Westchester, IL: American Academy of Sleep Medicine; Fernandez-Julian E, Munoz N, Achiques MT, Garcia-Perez MA, Orts M, Marco J. Randomized study comparing two tongue base surgeries for moderate to severe obstructive sleep apnea syndrome. Otolaryngol Head Neck Surg 2009;140: Nelson LM, Barrera JE. High energy single session radiofrequency tongue treatment in obstructive sleep apnea surgery. Otolaryngol Head Neck Surg 2007;137: Langin T, Pepin JL, Pendlebury S, Baranton-Cantin H, Ferretti G, Reyt E, Levy P. Upper airway changes in snorers and mild sleep apnea sufferers after uvulopalatopharyngoplasty (UPPP). Chest 1998;113: